Susan London

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to a randomized trial, which is the first of its kind. The study was reported at the annual meeting of the Pediatric Academic Societies.

Motivational interviewing is not new. It got its start in addiction medicine several decades ago, and only in the past decade has the technique made its way to chronic disease management. Lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor, explains the method and how it’s finding its place in pediatrics and primary care.

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to a randomized trial, which is the first of its kind. The study was reported at the annual meeting of the Pediatric Academic Societies.

Motivational interviewing is not new. It got its start in addiction medicine several decades ago, and only in the past decade has the technique made its way to chronic disease management. Lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor, explains the method and how it’s finding its place in pediatrics and primary care.

VANCOUVER, B.C. – Motivational interviewing in the primary care setting promotes weight loss among overweight and obese children, according to a randomized trial, which is the first of its kind. The study was reported at the annual meeting of the Pediatric Academic Societies.

Motivational interviewing is not new. It got its start in addiction medicine several decades ago, and only in the past decade has the technique made its way to chronic disease management. Lead author Ken Resnicow, Ph.D., professor of health behavior and health education, University of Michigan School of Public Health in Ann Arbor, explains the method and how it’s finding its place in pediatrics and primary care.

Patients with appendicitis who live in areas having a critical shortage of general surgeons are at increased risk for appendiceal rupture, finds a cross-sectional, observational study published in the Annals of Surgery.

Investigators used discharge data to identify 29,403 patients with acute appendicitis seen in acute care and ambulatory surgery facilities in North Carolina between 2007 and 2009. Diagnostic codes indicated that 24.6% overall had experienced rupture.

In multivariate analyses, the probability of rupture was a significant 4.8 percentage points higher for patients in surgical service areas having a critical shortage of general surgeons (fewer than 3 per 100,000 people) than for patients in areas not having any shortage (at least 5 per 100,000 people), the investigators report (Ann Surg. 2014;259:910-15). Patients living in areas having lesser shortages did not have significantly elevated risk.

In contrast, the primary care physician supply in a given surgical service area did not predict rupture on its own, although it did show an interaction with area, with greater supply increasing the probability of rupture in some areas having a general surgeon shortage and decreasing it in others.

"Although rupture risk also depends on several other determinants of access, the density of the local general surgery workforce may be the most important determinant of access for timely appendicitis care. The independent effect of living in a critical surgery shortage area was greater than that of race, insurance status, rural status, and admission source," the investigators note.

"Enhancing supply in critical shortage areas could reduce appendiceal rupture and improve surgical access more generally," they maintain.

At the same time, the findings regarding primary care physician supply also have implications for policies aimed at improving general surgeon supply, according to the investigators.

"These results underscore the need for an effectively targeted HPSA (health professional shortage area) surgical incentive payments policy," which currently provides a 10% bonus payment to general surgeons operating in primary care health professional shortage areas, they note. "The current rule for designation of a surgical HPSA assumes that they coincide with current primary care HPSAs and designates them accordingly. This assumption is not supported by our analysis."

The investigators disclosed no relevant conflicts of interest.

acssurgerynews@frontlinemednewscom.com

Patients with appendicitis who live in areas having a critical shortage of general surgeons are at increased risk for appendiceal rupture, finds a cross-sectional, observational study published in the Annals of Surgery.

Investigators used discharge data to identify 29,403 patients with acute appendicitis seen in acute care and ambulatory surgery facilities in North Carolina between 2007 and 2009. Diagnostic codes indicated that 24.6% overall had experienced rupture.

In multivariate analyses, the probability of rupture was a significant 4.8 percentage points higher for patients in surgical service areas having a critical shortage of general surgeons (fewer than 3 per 100,000 people) than for patients in areas not having any shortage (at least 5 per 100,000 people), the investigators report (Ann Surg. 2014;259:910-15). Patients living in areas having lesser shortages did not have significantly elevated risk.

In contrast, the primary care physician supply in a given surgical service area did not predict rupture on its own, although it did show an interaction with area, with greater supply increasing the probability of rupture in some areas having a general surgeon shortage and decreasing it in others.

"Although rupture risk also depends on several other determinants of access, the density of the local general surgery workforce may be the most important determinant of access for timely appendicitis care. The independent effect of living in a critical surgery shortage area was greater than that of race, insurance status, rural status, and admission source," the investigators note.

"Enhancing supply in critical shortage areas could reduce appendiceal rupture and improve surgical access more generally," they maintain.

At the same time, the findings regarding primary care physician supply also have implications for policies aimed at improving general surgeon supply, according to the investigators.

"These results underscore the need for an effectively targeted HPSA (health professional shortage area) surgical incentive payments policy," which currently provides a 10% bonus payment to general surgeons operating in primary care health professional shortage areas, they note. "The current rule for designation of a surgical HPSA assumes that they coincide with current primary care HPSAs and designates them accordingly. This assumption is not supported by our analysis."

The investigators disclosed no relevant conflicts of interest.

acssurgerynews@frontlinemednewscom.com

Patients with appendicitis who live in areas having a critical shortage of general surgeons are at increased risk for appendiceal rupture, finds a cross-sectional, observational study published in the Annals of Surgery.

Investigators used discharge data to identify 29,403 patients with acute appendicitis seen in acute care and ambulatory surgery facilities in North Carolina between 2007 and 2009. Diagnostic codes indicated that 24.6% overall had experienced rupture.

In multivariate analyses, the probability of rupture was a significant 4.8 percentage points higher for patients in surgical service areas having a critical shortage of general surgeons (fewer than 3 per 100,000 people) than for patients in areas not having any shortage (at least 5 per 100,000 people), the investigators report (Ann Surg. 2014;259:910-15). Patients living in areas having lesser shortages did not have significantly elevated risk.

In contrast, the primary care physician supply in a given surgical service area did not predict rupture on its own, although it did show an interaction with area, with greater supply increasing the probability of rupture in some areas having a general surgeon shortage and decreasing it in others.

"Although rupture risk also depends on several other determinants of access, the density of the local general surgery workforce may be the most important determinant of access for timely appendicitis care. The independent effect of living in a critical surgery shortage area was greater than that of race, insurance status, rural status, and admission source," the investigators note.

"Enhancing supply in critical shortage areas could reduce appendiceal rupture and improve surgical access more generally," they maintain.

At the same time, the findings regarding primary care physician supply also have implications for policies aimed at improving general surgeon supply, according to the investigators.

"These results underscore the need for an effectively targeted HPSA (health professional shortage area) surgical incentive payments policy," which currently provides a 10% bonus payment to general surgeons operating in primary care health professional shortage areas, they note. "The current rule for designation of a surgical HPSA assumes that they coincide with current primary care HPSAs and designates them accordingly. This assumption is not supported by our analysis."

The investigators disclosed no relevant conflicts of interest.

acssurgerynews@frontlinemednewscom.com

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – A simple model may help individualize the ordering of blood work after an uncomplicated hysterectomy done for benign indications, according to Dr. Carolyn W. Swenson.

Weight, preoperative hematocrit, and race independently predicted a higher hematocrit on postoperative day 1. Estimated blood loss, volume of intraoperative crystalloid used, preoperative platelet count, and use of intraoperative crystalloid as a dichotomous variable independently predicted a lower hematocrit, she said at the annual meeting of the Society of Gynecologic Surgeons.

Using a mathematical model based on the seven variables accurately predicted hematocrit on postoperative day 1 in 91% of cases, where accuracy was defined as a predicted hematocrit that fell within 4 percentage points of the actual value. "This may support the selective ordering of postoperative labs after hysterectomy, which not only would limit unnecessary lab tests for patients, but also increase the cost effectiveness of our medical care, which could lead to considerable cost savings," Dr. Swenson said at the meeting, jointly sponsored by the American College of Surgeons.

"At this conference, we have heard a lot about the importance of resource utilization in practice and cost-effective medical care," said lead investigator Dr. Swenson of the University of Michigan, Ann Arbor. "So if I told you there was an easy way to have one less thing to follow up on after a hysterectomy, there would be one less procedure for patients to undergo, and this simple thing could potentially save the health care system over $7 million a year, hopefully many of you would be interested."

Dr. Swenson and her colleagues analyzed data from 1,918 women who had hysterectomies in 2012 and validated the model in 366 comparable women operated on in 2013. The data came from the Michigan Surgical Quality Collaborative, which includes 49 community and academic hospitals. The researchers excluded patients with cancer or sepsis, those with obstetric or emergent indications, and patients receiving perioperative blood transfusions. The database included patients who had hysterectomies done for prolapse.

"In order to facilitate the use of this model, we are in the process of developing an iPhone app so that at the end of a case, a surgeon can easily and quickly calculate [the patient’s] predicted postop day 1 hematocrit, and then use that value along with their clinical judgment to decide whether or not to order this lab test," she said. "It’s just seven variables. You don’t need an iPhone app to be able to do it, but it just makes it a lot easier."

A complete blood cell count often is routinely ordered after a hysterectomy, yet "the literature shows that in the absence of any clinical suspicion, routine postoperative labs after gynecologic surgery essentially never affect clinical outcomes."

On average, the women studied were 47 years old and had a body mass index of 31 kg/m², reported Dr. Swenson. More than three-fourths were white, and about one-fourth were smokers. Hysterectomies were done by a variety of routes, with the largest share, roughly 40%, done laparoscopically.

Dr. Swenson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – A simple model may help individualize the ordering of blood work after an uncomplicated hysterectomy done for benign indications, according to Dr. Carolyn W. Swenson.

Weight, preoperative hematocrit, and race independently predicted a higher hematocrit on postoperative day 1. Estimated blood loss, volume of intraoperative crystalloid used, preoperative platelet count, and use of intraoperative crystalloid as a dichotomous variable independently predicted a lower hematocrit, she said at the annual meeting of the Society of Gynecologic Surgeons.

Using a mathematical model based on the seven variables accurately predicted hematocrit on postoperative day 1 in 91% of cases, where accuracy was defined as a predicted hematocrit that fell within 4 percentage points of the actual value. "This may support the selective ordering of postoperative labs after hysterectomy, which not only would limit unnecessary lab tests for patients, but also increase the cost effectiveness of our medical care, which could lead to considerable cost savings," Dr. Swenson said at the meeting, jointly sponsored by the American College of Surgeons.

"At this conference, we have heard a lot about the importance of resource utilization in practice and cost-effective medical care," said lead investigator Dr. Swenson of the University of Michigan, Ann Arbor. "So if I told you there was an easy way to have one less thing to follow up on after a hysterectomy, there would be one less procedure for patients to undergo, and this simple thing could potentially save the health care system over $7 million a year, hopefully many of you would be interested."

Dr. Swenson and her colleagues analyzed data from 1,918 women who had hysterectomies in 2012 and validated the model in 366 comparable women operated on in 2013. The data came from the Michigan Surgical Quality Collaborative, which includes 49 community and academic hospitals. The researchers excluded patients with cancer or sepsis, those with obstetric or emergent indications, and patients receiving perioperative blood transfusions. The database included patients who had hysterectomies done for prolapse.

"In order to facilitate the use of this model, we are in the process of developing an iPhone app so that at the end of a case, a surgeon can easily and quickly calculate [the patient’s] predicted postop day 1 hematocrit, and then use that value along with their clinical judgment to decide whether or not to order this lab test," she said. "It’s just seven variables. You don’t need an iPhone app to be able to do it, but it just makes it a lot easier."

A complete blood cell count often is routinely ordered after a hysterectomy, yet "the literature shows that in the absence of any clinical suspicion, routine postoperative labs after gynecologic surgery essentially never affect clinical outcomes."

On average, the women studied were 47 years old and had a body mass index of 31 kg/m², reported Dr. Swenson. More than three-fourths were white, and about one-fourth were smokers. Hysterectomies were done by a variety of routes, with the largest share, roughly 40%, done laparoscopically.

Dr. Swenson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – A simple model may help individualize the ordering of blood work after an uncomplicated hysterectomy done for benign indications, according to Dr. Carolyn W. Swenson.

Weight, preoperative hematocrit, and race independently predicted a higher hematocrit on postoperative day 1. Estimated blood loss, volume of intraoperative crystalloid used, preoperative platelet count, and use of intraoperative crystalloid as a dichotomous variable independently predicted a lower hematocrit, she said at the annual meeting of the Society of Gynecologic Surgeons.

Using a mathematical model based on the seven variables accurately predicted hematocrit on postoperative day 1 in 91% of cases, where accuracy was defined as a predicted hematocrit that fell within 4 percentage points of the actual value. "This may support the selective ordering of postoperative labs after hysterectomy, which not only would limit unnecessary lab tests for patients, but also increase the cost effectiveness of our medical care, which could lead to considerable cost savings," Dr. Swenson said at the meeting, jointly sponsored by the American College of Surgeons.

"At this conference, we have heard a lot about the importance of resource utilization in practice and cost-effective medical care," said lead investigator Dr. Swenson of the University of Michigan, Ann Arbor. "So if I told you there was an easy way to have one less thing to follow up on after a hysterectomy, there would be one less procedure for patients to undergo, and this simple thing could potentially save the health care system over $7 million a year, hopefully many of you would be interested."

Dr. Swenson and her colleagues analyzed data from 1,918 women who had hysterectomies in 2012 and validated the model in 366 comparable women operated on in 2013. The data came from the Michigan Surgical Quality Collaborative, which includes 49 community and academic hospitals. The researchers excluded patients with cancer or sepsis, those with obstetric or emergent indications, and patients receiving perioperative blood transfusions. The database included patients who had hysterectomies done for prolapse.

"In order to facilitate the use of this model, we are in the process of developing an iPhone app so that at the end of a case, a surgeon can easily and quickly calculate [the patient’s] predicted postop day 1 hematocrit, and then use that value along with their clinical judgment to decide whether or not to order this lab test," she said. "It’s just seven variables. You don’t need an iPhone app to be able to do it, but it just makes it a lot easier."

A complete blood cell count often is routinely ordered after a hysterectomy, yet "the literature shows that in the absence of any clinical suspicion, routine postoperative labs after gynecologic surgery essentially never affect clinical outcomes."

On average, the women studied were 47 years old and had a body mass index of 31 kg/m², reported Dr. Swenson. More than three-fourths were white, and about one-fourth were smokers. Hysterectomies were done by a variety of routes, with the largest share, roughly 40%, done laparoscopically.

Dr. Swenson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The number of apical pelvic organ prolapse repairs done each year in the United States has increased, but less invasive approaches have become the norm, a cross-sectional study spanning a 15-year period found.

Using data from the Medstat MarketScan database, which captures information on commercially insured individuals, researchers identified 53,980 women aged 18-65 years who underwent surgery for apical prolapse between 1996 and 2010.

The results showed that the number of procedures done each year rose steadily during the study period, first author Dr. Vani Dandolu reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

At the same time, there was a decrease in the proportion of procedures done abdominally, from 49% to 12%, and increases in the proportions done laparoscopically (including robotically), from 0% to 21%, and done vaginally, from 51% to 67%.

Among all vaginal procedures, the proportion in which mesh was used increased steadily after its approval in 2002, peaked in 2007, and fell thereafter with the first safety warning about this product by the Food and Drug Administration in 2008. As of 2010, about 18% of vaginal procedures were done with mesh.

"Surgical advances have brought new evolution in the repair of apical prolapse in the past decade," commented Dr. Dandolu, who is professor and chair of obstetrics and gynecology at the University of Nevada in Las Vegas. "Up until 2002, the data was fairly simple: About half the procedures performed were open sacrocolpopexies, and the other half were extraperitoneal vaginal suspensions, mainly sacrospinous fixations. Things changed in the second half of the study period – it became more complex, there was more variety of procedures.

"The proportion of abdominal sacrocolpopexies decreased sharply between 1996 and 2010. This corresponded to an increase in laparoscopic sacrocolpopexy and vaginal procedures, as well as the mesh repairs," she said.

A key advantage of the MarketScan database over other national databases is its high-quality coding, which permits precise categorization of the various types of prolapse repair, noted Dr. Dandolu.

"When you are looking at procedures, probably this is the most robust dataset because it gathers information both from the providers as well as the facilities. The providers typically record the procedures based on CPT [Current Procedural Terminology] procedure codes that are more precise than the facilities’ report based on ICD [International Classification of Diseases] procedure codes," she added.

Session attendee Dr. William Hurd of the Duke Fertility Center in Durham, N.C., asked, "Do you think the increased number of procedures is related to the aging population or to more people trained to do these procedures?"

"I think it’s a combination of several things – the two factors you mentioned, as well as more and more commercial insurers are reporting data into this dataset," Dr. Dandolu replied.

Attendee Dr. John Riggs of the University of Texas in Houston wondered if the CPT codes had changed in any way during the study period.

"The CPT codes for the laparoscopic sacrocolpopexies were introduced around 2003 and the mesh codes were introduced around 2005," Dr. Dandolu replied. "Otherwise, for the traditional procedures, the CPT procedural codes have not changed."

Finally, attendee Dr. Lisa Peacock of Louisiana State University Health Sciences Center in New Orleans asked, "Could you tell in your increase in laparoscopic procedures what proportion of that may be robotic?"

That information was not available as the database did not split out the robotic procedures until 2011, Dr. Dandolu said at the meeting, which was jointly sponsored by the American College of Surgeons.

Dr. Dandolu reported no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The number of apical pelvic organ prolapse repairs done each year in the United States has increased, but less invasive approaches have become the norm, a cross-sectional study spanning a 15-year period found.

Using data from the Medstat MarketScan database, which captures information on commercially insured individuals, researchers identified 53,980 women aged 18-65 years who underwent surgery for apical prolapse between 1996 and 2010.

The results showed that the number of procedures done each year rose steadily during the study period, first author Dr. Vani Dandolu reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

At the same time, there was a decrease in the proportion of procedures done abdominally, from 49% to 12%, and increases in the proportions done laparoscopically (including robotically), from 0% to 21%, and done vaginally, from 51% to 67%.

Among all vaginal procedures, the proportion in which mesh was used increased steadily after its approval in 2002, peaked in 2007, and fell thereafter with the first safety warning about this product by the Food and Drug Administration in 2008. As of 2010, about 18% of vaginal procedures were done with mesh.

"Surgical advances have brought new evolution in the repair of apical prolapse in the past decade," commented Dr. Dandolu, who is professor and chair of obstetrics and gynecology at the University of Nevada in Las Vegas. "Up until 2002, the data was fairly simple: About half the procedures performed were open sacrocolpopexies, and the other half were extraperitoneal vaginal suspensions, mainly sacrospinous fixations. Things changed in the second half of the study period – it became more complex, there was more variety of procedures.

"The proportion of abdominal sacrocolpopexies decreased sharply between 1996 and 2010. This corresponded to an increase in laparoscopic sacrocolpopexy and vaginal procedures, as well as the mesh repairs," she said.

A key advantage of the MarketScan database over other national databases is its high-quality coding, which permits precise categorization of the various types of prolapse repair, noted Dr. Dandolu.

"When you are looking at procedures, probably this is the most robust dataset because it gathers information both from the providers as well as the facilities. The providers typically record the procedures based on CPT [Current Procedural Terminology] procedure codes that are more precise than the facilities’ report based on ICD [International Classification of Diseases] procedure codes," she added.

Session attendee Dr. William Hurd of the Duke Fertility Center in Durham, N.C., asked, "Do you think the increased number of procedures is related to the aging population or to more people trained to do these procedures?"

"I think it’s a combination of several things – the two factors you mentioned, as well as more and more commercial insurers are reporting data into this dataset," Dr. Dandolu replied.

Attendee Dr. John Riggs of the University of Texas in Houston wondered if the CPT codes had changed in any way during the study period.

"The CPT codes for the laparoscopic sacrocolpopexies were introduced around 2003 and the mesh codes were introduced around 2005," Dr. Dandolu replied. "Otherwise, for the traditional procedures, the CPT procedural codes have not changed."

Finally, attendee Dr. Lisa Peacock of Louisiana State University Health Sciences Center in New Orleans asked, "Could you tell in your increase in laparoscopic procedures what proportion of that may be robotic?"

That information was not available as the database did not split out the robotic procedures until 2011, Dr. Dandolu said at the meeting, which was jointly sponsored by the American College of Surgeons.

Dr. Dandolu reported no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The number of apical pelvic organ prolapse repairs done each year in the United States has increased, but less invasive approaches have become the norm, a cross-sectional study spanning a 15-year period found.

Using data from the Medstat MarketScan database, which captures information on commercially insured individuals, researchers identified 53,980 women aged 18-65 years who underwent surgery for apical prolapse between 1996 and 2010.

The results showed that the number of procedures done each year rose steadily during the study period, first author Dr. Vani Dandolu reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

At the same time, there was a decrease in the proportion of procedures done abdominally, from 49% to 12%, and increases in the proportions done laparoscopically (including robotically), from 0% to 21%, and done vaginally, from 51% to 67%.

Among all vaginal procedures, the proportion in which mesh was used increased steadily after its approval in 2002, peaked in 2007, and fell thereafter with the first safety warning about this product by the Food and Drug Administration in 2008. As of 2010, about 18% of vaginal procedures were done with mesh.

"Surgical advances have brought new evolution in the repair of apical prolapse in the past decade," commented Dr. Dandolu, who is professor and chair of obstetrics and gynecology at the University of Nevada in Las Vegas. "Up until 2002, the data was fairly simple: About half the procedures performed were open sacrocolpopexies, and the other half were extraperitoneal vaginal suspensions, mainly sacrospinous fixations. Things changed in the second half of the study period – it became more complex, there was more variety of procedures.

"The proportion of abdominal sacrocolpopexies decreased sharply between 1996 and 2010. This corresponded to an increase in laparoscopic sacrocolpopexy and vaginal procedures, as well as the mesh repairs," she said.

A key advantage of the MarketScan database over other national databases is its high-quality coding, which permits precise categorization of the various types of prolapse repair, noted Dr. Dandolu.

"When you are looking at procedures, probably this is the most robust dataset because it gathers information both from the providers as well as the facilities. The providers typically record the procedures based on CPT [Current Procedural Terminology] procedure codes that are more precise than the facilities’ report based on ICD [International Classification of Diseases] procedure codes," she added.

Session attendee Dr. William Hurd of the Duke Fertility Center in Durham, N.C., asked, "Do you think the increased number of procedures is related to the aging population or to more people trained to do these procedures?"

"I think it’s a combination of several things – the two factors you mentioned, as well as more and more commercial insurers are reporting data into this dataset," Dr. Dandolu replied.

Attendee Dr. John Riggs of the University of Texas in Houston wondered if the CPT codes had changed in any way during the study period.

"The CPT codes for the laparoscopic sacrocolpopexies were introduced around 2003 and the mesh codes were introduced around 2005," Dr. Dandolu replied. "Otherwise, for the traditional procedures, the CPT procedural codes have not changed."

Finally, attendee Dr. Lisa Peacock of Louisiana State University Health Sciences Center in New Orleans asked, "Could you tell in your increase in laparoscopic procedures what proportion of that may be robotic?"

That information was not available as the database did not split out the robotic procedures until 2011, Dr. Dandolu said at the meeting, which was jointly sponsored by the American College of Surgeons.

Dr. Dandolu reported no relevant conflicts of interest.

Adults with schizophrenia who threaten or attempt suicide have sharply increased risks of becoming violent, according to a recently published analysis.

Katrina Witt, a doctoral candidate affiliated with the University of Oxford (England), and her associates analyzed longitudinal data from the National Institute of Mental Health’s CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness), a randomized controlled trial of antipsychotic medication in 1,460 adults with schizophrenia of generally moderate severity who were receiving usual care.

During a median follow-up of 15.7 months, 33.7% of the patients experienced suicidal ideation, 11.1% threatened suicide, and 5.8% attempted suicide, Ms. Witt and her associates reported (Schizophr. Res. 2014;154:61-7). About 8.3% of the patients showed violent behavior at some time as ascertained from interviews with family members.

In univariate analyses, suicidal threats and suicide attempts were significantly associated with violent behavior in both sexes, whereas suicidal ideation was not significantly associated for either sex.

In multivariate analyses that adjusted for a variety of comorbidities (alcohol misuse, drug misuse, diagnosed major depressive disorder, or diagnosed antisocial personality disorder), men and women had significantly elevated risks of violence if they made suicidal threats (hazard ratios, 3.8 and 9.4) or attempted suicide (hazard ratios, 2.8 and 4.4).

Additionally, for both sexes, the risks were elevated by roughly the same extent after adjustment for age or baseline scores for depression, hostility, positive symptoms, or poor impulse control. In women, adjustment for 6-month scores on these measures also made little difference; however, in men, adjustment abolished the significant association between suicide attempts and subsequent violence.

Of the three suicidality measures, suicidal threats yielded the greatest improvement in the prediction of violence for both sexes when added to a baseline risk model consisting of age, comorbid substance use disorder, and previous violence.

Ms. Witt and her associates cited several limitations. First, randomized controlled trials of antipsychotic effectiveness are "less likely to recruit individuals reporting thoughts of suicidality and self-harm." In light of that fact, it might not be possible to generalize the results of this study to all patients with schizophrenia.

Also, the CATIE data were not collected to meet the aims of this study, and as a result, it was not possible to include relevant confounding factors such as intelligence scores and "neighborhood socioeconomic deprivation."

Nevertheless, they said, their findings have implications for clinical care and for possible explanatory mechanisms.

"First, as part of the clinical risk assessment of violence in schizophrenia, as recommended by clinical guidelines in both the [United States] and [United Kingdom], a careful examination of history of suicidality should be included," they wrote.

"Second, the association between suicidal attempts and violence may be modified by 6-month depression, hostility, positive symptomatology, and poor impulse control scores in males. Given that medication adherence was monitored during the CATIE trial, this finding may suggest that acute symptomatology, perhaps exacerbated by medication nonadherence, may account for some of the association between suicidality and violence in males," they maintained. Thus efforts to ensure adherence might improve outcomes.

The investigators disclosed no conflicts of interest. The study was funded in part by the Wellcome Trust.

Adults with schizophrenia who threaten or attempt suicide have sharply increased risks of becoming violent, according to a recently published analysis.

Katrina Witt, a doctoral candidate affiliated with the University of Oxford (England), and her associates analyzed longitudinal data from the National Institute of Mental Health’s CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness), a randomized controlled trial of antipsychotic medication in 1,460 adults with schizophrenia of generally moderate severity who were receiving usual care.

During a median follow-up of 15.7 months, 33.7% of the patients experienced suicidal ideation, 11.1% threatened suicide, and 5.8% attempted suicide, Ms. Witt and her associates reported (Schizophr. Res. 2014;154:61-7). About 8.3% of the patients showed violent behavior at some time as ascertained from interviews with family members.

In univariate analyses, suicidal threats and suicide attempts were significantly associated with violent behavior in both sexes, whereas suicidal ideation was not significantly associated for either sex.

In multivariate analyses that adjusted for a variety of comorbidities (alcohol misuse, drug misuse, diagnosed major depressive disorder, or diagnosed antisocial personality disorder), men and women had significantly elevated risks of violence if they made suicidal threats (hazard ratios, 3.8 and 9.4) or attempted suicide (hazard ratios, 2.8 and 4.4).

Additionally, for both sexes, the risks were elevated by roughly the same extent after adjustment for age or baseline scores for depression, hostility, positive symptoms, or poor impulse control. In women, adjustment for 6-month scores on these measures also made little difference; however, in men, adjustment abolished the significant association between suicide attempts and subsequent violence.

Of the three suicidality measures, suicidal threats yielded the greatest improvement in the prediction of violence for both sexes when added to a baseline risk model consisting of age, comorbid substance use disorder, and previous violence.

Ms. Witt and her associates cited several limitations. First, randomized controlled trials of antipsychotic effectiveness are "less likely to recruit individuals reporting thoughts of suicidality and self-harm." In light of that fact, it might not be possible to generalize the results of this study to all patients with schizophrenia.

Also, the CATIE data were not collected to meet the aims of this study, and as a result, it was not possible to include relevant confounding factors such as intelligence scores and "neighborhood socioeconomic deprivation."

Nevertheless, they said, their findings have implications for clinical care and for possible explanatory mechanisms.

"First, as part of the clinical risk assessment of violence in schizophrenia, as recommended by clinical guidelines in both the [United States] and [United Kingdom], a careful examination of history of suicidality should be included," they wrote.

"Second, the association between suicidal attempts and violence may be modified by 6-month depression, hostility, positive symptomatology, and poor impulse control scores in males. Given that medication adherence was monitored during the CATIE trial, this finding may suggest that acute symptomatology, perhaps exacerbated by medication nonadherence, may account for some of the association between suicidality and violence in males," they maintained. Thus efforts to ensure adherence might improve outcomes.

The investigators disclosed no conflicts of interest. The study was funded in part by the Wellcome Trust.

Adults with schizophrenia who threaten or attempt suicide have sharply increased risks of becoming violent, according to a recently published analysis.

Katrina Witt, a doctoral candidate affiliated with the University of Oxford (England), and her associates analyzed longitudinal data from the National Institute of Mental Health’s CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness), a randomized controlled trial of antipsychotic medication in 1,460 adults with schizophrenia of generally moderate severity who were receiving usual care.

During a median follow-up of 15.7 months, 33.7% of the patients experienced suicidal ideation, 11.1% threatened suicide, and 5.8% attempted suicide, Ms. Witt and her associates reported (Schizophr. Res. 2014;154:61-7). About 8.3% of the patients showed violent behavior at some time as ascertained from interviews with family members.

In univariate analyses, suicidal threats and suicide attempts were significantly associated with violent behavior in both sexes, whereas suicidal ideation was not significantly associated for either sex.

In multivariate analyses that adjusted for a variety of comorbidities (alcohol misuse, drug misuse, diagnosed major depressive disorder, or diagnosed antisocial personality disorder), men and women had significantly elevated risks of violence if they made suicidal threats (hazard ratios, 3.8 and 9.4) or attempted suicide (hazard ratios, 2.8 and 4.4).

Additionally, for both sexes, the risks were elevated by roughly the same extent after adjustment for age or baseline scores for depression, hostility, positive symptoms, or poor impulse control. In women, adjustment for 6-month scores on these measures also made little difference; however, in men, adjustment abolished the significant association between suicide attempts and subsequent violence.

Of the three suicidality measures, suicidal threats yielded the greatest improvement in the prediction of violence for both sexes when added to a baseline risk model consisting of age, comorbid substance use disorder, and previous violence.

Ms. Witt and her associates cited several limitations. First, randomized controlled trials of antipsychotic effectiveness are "less likely to recruit individuals reporting thoughts of suicidality and self-harm." In light of that fact, it might not be possible to generalize the results of this study to all patients with schizophrenia.

Also, the CATIE data were not collected to meet the aims of this study, and as a result, it was not possible to include relevant confounding factors such as intelligence scores and "neighborhood socioeconomic deprivation."

Nevertheless, they said, their findings have implications for clinical care and for possible explanatory mechanisms.

"First, as part of the clinical risk assessment of violence in schizophrenia, as recommended by clinical guidelines in both the [United States] and [United Kingdom], a careful examination of history of suicidality should be included," they wrote.

"Second, the association between suicidal attempts and violence may be modified by 6-month depression, hostility, positive symptomatology, and poor impulse control scores in males. Given that medication adherence was monitored during the CATIE trial, this finding may suggest that acute symptomatology, perhaps exacerbated by medication nonadherence, may account for some of the association between suicidality and violence in males," they maintained. Thus efforts to ensure adherence might improve outcomes.

The investigators disclosed no conflicts of interest. The study was funded in part by the Wellcome Trust.

Routinely measuring aspects of health status from the oncology patient’s point of view and using these measures in care improves selected outcomes, according to Grigorios Kotronoulas, Ph.D., and his associates.

The report was published online April 7 in Journal of Clinical Oncology.

For a systematic review, Dr. Kotronoulas and his associates searched five electronic databases through May 2012 to identify controlled trials (whether randomized or not) that tested patient-reported outcome measure (PROM) interventions among adults receiving active anticancer treatment or supportive care, irrespective of type of cancer or stage. The trials had to provide PROM-generated feedback to health care professionals or patients in an effort to improve the quality of care.

The investigators assessed potential impact of the routine PROM use in three broad areas: patient outcomes (e.g., symptom burden, health-related quality of life), processes of care (patient adherence and satisfaction, patient–health professional communication, referrals), and health service outcomes (patient safety, cost-effectiveness).

The search identified 26 articles that reported on 24 unique controlled trials having a total of 6,279 patients and 713 health professionals, reported Dr. Kotronoulas of University of Surrey, Guildford, England, and his colleagues.

The trials had a wide range of designs and used diverse interventions (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.53.5948]). In addition, the outcomes evaluated and cancer- and modality-specific context varied considerably. Although 87.5% of trials reported on patient outcomes and 79.2% reported on processes of care, only 20.8% reported any health service outcomes as endpoints.

Analyses showed that overall, there were few statistically significant associations between routine use of PROMs and a variety of outcomes. Additionally, the intervention effect sizes were generally small to moderate.

Routine use of PROMs did increase the frequency of discussion of patient outcomes during consultations. Interventions had the greatest impact in the context of palliative chemotherapy, where they improved discussion of dyspnea; social functioning and fatigue; and sleep problems, constipation, diarrhea, and cognitive functioning.

Seven trials found that PROMs were associated with improved symptom control, positive effects seen in terms of reduced prevalence or severity of physical symptoms, and reduced prevalence, severity, or impact of psychological symptoms, the investigators reported.

Some trials found PROMs to be associated with increased supportive care measures and greater patient satisfaction.

"More research is necessary on the effects of PROM interventions on health outcomes across different types of cancers and treatment modalities," the researchers wrote.

"Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health," they added.

Dr. Kotronoulas reported no disclosures. Dr. Nora Kearney, a coauthor, disclosed that she received funding from Philips HealthCare. The other authors disclosed no conflicts of interest.

Routinely measuring aspects of health status from the oncology patient’s point of view and using these measures in care improves selected outcomes, according to Grigorios Kotronoulas, Ph.D., and his associates.

The report was published online April 7 in Journal of Clinical Oncology.

For a systematic review, Dr. Kotronoulas and his associates searched five electronic databases through May 2012 to identify controlled trials (whether randomized or not) that tested patient-reported outcome measure (PROM) interventions among adults receiving active anticancer treatment or supportive care, irrespective of type of cancer or stage. The trials had to provide PROM-generated feedback to health care professionals or patients in an effort to improve the quality of care.

The investigators assessed potential impact of the routine PROM use in three broad areas: patient outcomes (e.g., symptom burden, health-related quality of life), processes of care (patient adherence and satisfaction, patient–health professional communication, referrals), and health service outcomes (patient safety, cost-effectiveness).

The search identified 26 articles that reported on 24 unique controlled trials having a total of 6,279 patients and 713 health professionals, reported Dr. Kotronoulas of University of Surrey, Guildford, England, and his colleagues.

The trials had a wide range of designs and used diverse interventions (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.53.5948]). In addition, the outcomes evaluated and cancer- and modality-specific context varied considerably. Although 87.5% of trials reported on patient outcomes and 79.2% reported on processes of care, only 20.8% reported any health service outcomes as endpoints.

Analyses showed that overall, there were few statistically significant associations between routine use of PROMs and a variety of outcomes. Additionally, the intervention effect sizes were generally small to moderate.

Routine use of PROMs did increase the frequency of discussion of patient outcomes during consultations. Interventions had the greatest impact in the context of palliative chemotherapy, where they improved discussion of dyspnea; social functioning and fatigue; and sleep problems, constipation, diarrhea, and cognitive functioning.

Seven trials found that PROMs were associated with improved symptom control, positive effects seen in terms of reduced prevalence or severity of physical symptoms, and reduced prevalence, severity, or impact of psychological symptoms, the investigators reported.

Some trials found PROMs to be associated with increased supportive care measures and greater patient satisfaction.

"More research is necessary on the effects of PROM interventions on health outcomes across different types of cancers and treatment modalities," the researchers wrote.

"Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health," they added.

Dr. Kotronoulas reported no disclosures. Dr. Nora Kearney, a coauthor, disclosed that she received funding from Philips HealthCare. The other authors disclosed no conflicts of interest.

Routinely measuring aspects of health status from the oncology patient’s point of view and using these measures in care improves selected outcomes, according to Grigorios Kotronoulas, Ph.D., and his associates.

The report was published online April 7 in Journal of Clinical Oncology.

For a systematic review, Dr. Kotronoulas and his associates searched five electronic databases through May 2012 to identify controlled trials (whether randomized or not) that tested patient-reported outcome measure (PROM) interventions among adults receiving active anticancer treatment or supportive care, irrespective of type of cancer or stage. The trials had to provide PROM-generated feedback to health care professionals or patients in an effort to improve the quality of care.

The investigators assessed potential impact of the routine PROM use in three broad areas: patient outcomes (e.g., symptom burden, health-related quality of life), processes of care (patient adherence and satisfaction, patient–health professional communication, referrals), and health service outcomes (patient safety, cost-effectiveness).

The search identified 26 articles that reported on 24 unique controlled trials having a total of 6,279 patients and 713 health professionals, reported Dr. Kotronoulas of University of Surrey, Guildford, England, and his colleagues.

The trials had a wide range of designs and used diverse interventions (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.53.5948]). In addition, the outcomes evaluated and cancer- and modality-specific context varied considerably. Although 87.5% of trials reported on patient outcomes and 79.2% reported on processes of care, only 20.8% reported any health service outcomes as endpoints.

Analyses showed that overall, there were few statistically significant associations between routine use of PROMs and a variety of outcomes. Additionally, the intervention effect sizes were generally small to moderate.

Routine use of PROMs did increase the frequency of discussion of patient outcomes during consultations. Interventions had the greatest impact in the context of palliative chemotherapy, where they improved discussion of dyspnea; social functioning and fatigue; and sleep problems, constipation, diarrhea, and cognitive functioning.

Seven trials found that PROMs were associated with improved symptom control, positive effects seen in terms of reduced prevalence or severity of physical symptoms, and reduced prevalence, severity, or impact of psychological symptoms, the investigators reported.

Some trials found PROMs to be associated with increased supportive care measures and greater patient satisfaction.

"More research is necessary on the effects of PROM interventions on health outcomes across different types of cancers and treatment modalities," the researchers wrote.

"Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health," they added.

Dr. Kotronoulas reported no disclosures. Dr. Nora Kearney, a coauthor, disclosed that she received funding from Philips HealthCare. The other authors disclosed no conflicts of interest.

A pair of new indices may help individualize prognostication and treatment for adults with cytogenetically normal acute myeloid leukemia, the largest and most heterogeneous cytogenetic subgroup, Dr. Friederike Pastore and associates reported in Journal of Clinical Oncology.

The indices are likely the first that can be applied to adult patients with acute myeloid leukemia (AML) of all ages, wrote Dr. Pastore of University Hospital Munich, Germany, and his associates.

The investigators developed and validated the indices using data from 669 patients with cytogenetically normal disease who were treated within the German AML Cooperative Group 99 study.

Median age of the patients was 60 years, with a range from 17 to 85 years. Median overall survival was 1.9 years and median relapse-free survival was 1.5 years. About two-thirds of the patients had a treatment response, Dr. Pastore and associates reported.

The indices were based on the 572 patients with complete data and included age, performance status, white blood cell count, and mutation status of NPM1, CEBPA, and FLT3-internal tandem duplication, the investigators reported (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.52.3480).

The prognostic index for cytogenetically normal AML for overall survival classified 29%, 56%, and 15% of all patients as having low-, intermediate-, and high-risk disease, respectively. Their corresponding 5-year rates of overall survival were 74%, 28%, and 3% (P less than .001).

The prognostic index for cytogenetically normal AML for relapse-free survival classified 32%, 39%, and 29% of patients a treatment response as having low-, intermediate-, and high-risk disease. Their corresponding 5-year rates of relapse-free survival were 55%, 27%, and 5% (P less than .001).

Both indices performed well at stratifying patients within European LeukemiaNet genetic groups, and both were externally validated in a cohort of 529 patients treated in Cancer and Leukemia Group B/Alliance trials.

"We have developed and validated, to our knowledge, the first prognostic indices specifically designed for adult patients of all ages with [cytogenetically normal AML] that combine well-established molecular and clinical variables and that are easily applicable in routine clinical care," the investigators wrote, noting that web-based calculators for the indices are now accessible online.

"The new prognostic indices should be able to be easily adopted in routine practice for prognostication and guidance of risk-adapted postremission therapy in analogy to the Euro score ... in chronic myelogenous leukemia or the mantle cell lymphoma international prognostic index," they concluded.

The investigators disclosed no potential conflicts of interest.

A pair of new indices may help individualize prognostication and treatment for adults with cytogenetically normal acute myeloid leukemia, the largest and most heterogeneous cytogenetic subgroup, Dr. Friederike Pastore and associates reported in Journal of Clinical Oncology.

The indices are likely the first that can be applied to adult patients with acute myeloid leukemia (AML) of all ages, wrote Dr. Pastore of University Hospital Munich, Germany, and his associates.

The investigators developed and validated the indices using data from 669 patients with cytogenetically normal disease who were treated within the German AML Cooperative Group 99 study.

Median age of the patients was 60 years, with a range from 17 to 85 years. Median overall survival was 1.9 years and median relapse-free survival was 1.5 years. About two-thirds of the patients had a treatment response, Dr. Pastore and associates reported.

The indices were based on the 572 patients with complete data and included age, performance status, white blood cell count, and mutation status of NPM1, CEBPA, and FLT3-internal tandem duplication, the investigators reported (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.52.3480).

The prognostic index for cytogenetically normal AML for overall survival classified 29%, 56%, and 15% of all patients as having low-, intermediate-, and high-risk disease, respectively. Their corresponding 5-year rates of overall survival were 74%, 28%, and 3% (P less than .001).

The prognostic index for cytogenetically normal AML for relapse-free survival classified 32%, 39%, and 29% of patients a treatment response as having low-, intermediate-, and high-risk disease. Their corresponding 5-year rates of relapse-free survival were 55%, 27%, and 5% (P less than .001).

Both indices performed well at stratifying patients within European LeukemiaNet genetic groups, and both were externally validated in a cohort of 529 patients treated in Cancer and Leukemia Group B/Alliance trials.

"We have developed and validated, to our knowledge, the first prognostic indices specifically designed for adult patients of all ages with [cytogenetically normal AML] that combine well-established molecular and clinical variables and that are easily applicable in routine clinical care," the investigators wrote, noting that web-based calculators for the indices are now accessible online.

"The new prognostic indices should be able to be easily adopted in routine practice for prognostication and guidance of risk-adapted postremission therapy in analogy to the Euro score ... in chronic myelogenous leukemia or the mantle cell lymphoma international prognostic index," they concluded.

The investigators disclosed no potential conflicts of interest.

A pair of new indices may help individualize prognostication and treatment for adults with cytogenetically normal acute myeloid leukemia, the largest and most heterogeneous cytogenetic subgroup, Dr. Friederike Pastore and associates reported in Journal of Clinical Oncology.

The indices are likely the first that can be applied to adult patients with acute myeloid leukemia (AML) of all ages, wrote Dr. Pastore of University Hospital Munich, Germany, and his associates.

The investigators developed and validated the indices using data from 669 patients with cytogenetically normal disease who were treated within the German AML Cooperative Group 99 study.

Median age of the patients was 60 years, with a range from 17 to 85 years. Median overall survival was 1.9 years and median relapse-free survival was 1.5 years. About two-thirds of the patients had a treatment response, Dr. Pastore and associates reported.

The indices were based on the 572 patients with complete data and included age, performance status, white blood cell count, and mutation status of NPM1, CEBPA, and FLT3-internal tandem duplication, the investigators reported (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.52.3480).

The prognostic index for cytogenetically normal AML for overall survival classified 29%, 56%, and 15% of all patients as having low-, intermediate-, and high-risk disease, respectively. Their corresponding 5-year rates of overall survival were 74%, 28%, and 3% (P less than .001).

The prognostic index for cytogenetically normal AML for relapse-free survival classified 32%, 39%, and 29% of patients a treatment response as having low-, intermediate-, and high-risk disease. Their corresponding 5-year rates of relapse-free survival were 55%, 27%, and 5% (P less than .001).

Both indices performed well at stratifying patients within European LeukemiaNet genetic groups, and both were externally validated in a cohort of 529 patients treated in Cancer and Leukemia Group B/Alliance trials.

"We have developed and validated, to our knowledge, the first prognostic indices specifically designed for adult patients of all ages with [cytogenetically normal AML] that combine well-established molecular and clinical variables and that are easily applicable in routine clinical care," the investigators wrote, noting that web-based calculators for the indices are now accessible online.

"The new prognostic indices should be able to be easily adopted in routine practice for prognostication and guidance of risk-adapted postremission therapy in analogy to the Euro score ... in chronic myelogenous leukemia or the mantle cell lymphoma international prognostic index," they concluded.

The investigators disclosed no potential conflicts of interest.

SCOTTSDALE, ARIZ. – Patients giving consent to undergo midurethral sling surgery are more likely to remember being advised of the risks of surgical mesh if their surgeon speaks at a lower grade level.

This was among the key findings of a longitudinal cohort study of 71 women reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Analysis of the consent discussions, which lasted an average of 15 minutes, showed that surgeons were significantly more likely to mention the immediate risks of mesh than the long-term risks, reported first author Dr. Brook L. McFadden, a urogynecologist at the Ohio State University Wexner Medical Center in Columbus. But patients were equally likely to remember both groups of risks.

Neither the specific term surgeons used to refer to the midurethral sling implant – mesh, tape, or graft – nor the number of times they used the term during the discussion affected patients’ recall of mesh risks 6 weeks after surgery. The length of the discussion also had no significant impact.

However, the lower the grade level at which the surgeon spoke, the greater patients’ recall of risks, even though the cohort was fairly well educated. On average, the surgeons spoke at about the 6th- to 7th-grade level.

"This was a homogeneous, young, educated population, which may not be generalizable," Dr. McFadden noted. "And we cannot account for counseling that occurred prior to or after the surgical consent session that may have impacted recall."

Invited discussant Dr. Bela Kudish, a urogynecologist at the Winnie Palmer Hospital Center for Advanced Gynecologic Surgery and Pelvic Medicine in Orlando, noted, "As providers, many of us are trying to balance the principles of nonmaleficence, beneficence, and autonomy of the patient in an attempt to improve the counseling process, to emphasize the shared responsibility in decision making in patients who undergo this procedure."

"How are you planning to improve the study design to identify factors specific to the consent process that may influence the recall, since this was a study that was done in four centers with a nonstandardized consent process?" she asked the investigators.

"I think at this point, the surgical consent process is not limited to that moment that you sign papers. It starts in the first moment when you meet the patient. So I think we need to start broadening our understanding and our evaluation of the consent process to include the very beginning counseling that’s occurring from day 1. And I also think we need to spend more time trying to reconcile what patients want to know and what they think is important with what we want them to remember, maybe what the lawyers want them to remember, and try to make that more patient centered," Dr. McFadden replied at the meeting, which was jointly sponsored by the American College of Surgeons.

"In your opinion, what is the ideal way of counseling patients to increase the recall of risk?" Dr. Kudish further queried.

"I do try to spend time asking the patient, ‘How do you best learn? Is it written, is it verbal? Do you like pictures?’ And try to incorporate what works best for them. And I think that the utility of decisional aids, while we have presented work that did not show great use recently, that is where this is going to go: using decisional aids starting from the very beginning, day 1, up until surgery, and even beyond this," Dr. McFadden maintained.

Session cochair Dr. Andrew Cassidenti of St. Joseph Hospital, Orange, Calif., commented, "Your point is excellent. I think the informed consent is really your relationship with the patient. It’s not a document, it’s a relationship and it’s an understanding of your confidence, your capabilities, your experience, what you can do for them, your results, and an honest discussion. I think that really is the key to keeping lawyers at bay."

The study enrolled patients who could read and write English and were undergoing only midurethral sling surgery. "At these four centers, we did not specify specifically how the surgeons were to [address] consent. They did this all in their normal way, so that had variation," Dr. McFadden noted.

Consent discussions were audio recorded and transcribed, and the transcripts were analyzed for their content and grade level of the surgeon’s speech according to the Flesch-Kincaid scale.

Patients completed a 21-item recall checklist. Their recall score was calculated as the number of items recalled divided by the number the surgeon actually mentioned, multiplied by 100.

The patients’ mean age was 53 years; 83% were white and 66% had some college education or more, reported Dr. McFadden. On average, they had almost 15 years of education.

The percentage of physicians who mentioned various immediate risks of mesh ranged from 94% for bleeding to 97% for organ damage (mean, 95%). Patient recall scores at 6 weeks after surgery ranged from 71% for bleeding to 90% for the need for a catheter (mean, 80%).

The percentage of physicians who mentioned the long-term risks of mesh ranged from 30% for continued leakage and groin pain to 92% for mesh erosion, a notable high outlier (mean, 58%). Patient recall scores ranged from 33% for chronic urinary tract infection to 95% for continued leakage (mean, 68%).

Surgeons were significantly more likely to mention the immediate risks than the long-term risks (95% vs. 58%; P less than .01), but patients were similarly likely to recall these two groups of risks.

When referring to the midurethral sling implant, surgeons most commonly used the terms mesh (87%) and tape (81%), and less commonly used the term graft (14%). On average, there were 5.9 uses of mesh per consent session, 7.4 uses of tape, and 0.5 uses of graft.

A variety of sociodemographic factors (patient age, education, race/ethnicity, and health literacy score) and consent-related factors (duration of the discussion, mesh term used, and number of uses) were not significantly associated with patients’ recall of risks.

But the lower the grade level at which the surgeon spoke, the greater patients’ recall was (r = –0.26, P less than .05).

Dr. McFadden disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Patients giving consent to undergo midurethral sling surgery are more likely to remember being advised of the risks of surgical mesh if their surgeon speaks at a lower grade level.

This was among the key findings of a longitudinal cohort study of 71 women reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Analysis of the consent discussions, which lasted an average of 15 minutes, showed that surgeons were significantly more likely to mention the immediate risks of mesh than the long-term risks, reported first author Dr. Brook L. McFadden, a urogynecologist at the Ohio State University Wexner Medical Center in Columbus. But patients were equally likely to remember both groups of risks.

Neither the specific term surgeons used to refer to the midurethral sling implant – mesh, tape, or graft – nor the number of times they used the term during the discussion affected patients’ recall of mesh risks 6 weeks after surgery. The length of the discussion also had no significant impact.

However, the lower the grade level at which the surgeon spoke, the greater patients’ recall of risks, even though the cohort was fairly well educated. On average, the surgeons spoke at about the 6th- to 7th-grade level.

"This was a homogeneous, young, educated population, which may not be generalizable," Dr. McFadden noted. "And we cannot account for counseling that occurred prior to or after the surgical consent session that may have impacted recall."

Invited discussant Dr. Bela Kudish, a urogynecologist at the Winnie Palmer Hospital Center for Advanced Gynecologic Surgery and Pelvic Medicine in Orlando, noted, "As providers, many of us are trying to balance the principles of nonmaleficence, beneficence, and autonomy of the patient in an attempt to improve the counseling process, to emphasize the shared responsibility in decision making in patients who undergo this procedure."

"How are you planning to improve the study design to identify factors specific to the consent process that may influence the recall, since this was a study that was done in four centers with a nonstandardized consent process?" she asked the investigators.

"I think at this point, the surgical consent process is not limited to that moment that you sign papers. It starts in the first moment when you meet the patient. So I think we need to start broadening our understanding and our evaluation of the consent process to include the very beginning counseling that’s occurring from day 1. And I also think we need to spend more time trying to reconcile what patients want to know and what they think is important with what we want them to remember, maybe what the lawyers want them to remember, and try to make that more patient centered," Dr. McFadden replied at the meeting, which was jointly sponsored by the American College of Surgeons.

"In your opinion, what is the ideal way of counseling patients to increase the recall of risk?" Dr. Kudish further queried.

"I do try to spend time asking the patient, ‘How do you best learn? Is it written, is it verbal? Do you like pictures?’ And try to incorporate what works best for them. And I think that the utility of decisional aids, while we have presented work that did not show great use recently, that is where this is going to go: using decisional aids starting from the very beginning, day 1, up until surgery, and even beyond this," Dr. McFadden maintained.

Session cochair Dr. Andrew Cassidenti of St. Joseph Hospital, Orange, Calif., commented, "Your point is excellent. I think the informed consent is really your relationship with the patient. It’s not a document, it’s a relationship and it’s an understanding of your confidence, your capabilities, your experience, what you can do for them, your results, and an honest discussion. I think that really is the key to keeping lawyers at bay."

The study enrolled patients who could read and write English and were undergoing only midurethral sling surgery. "At these four centers, we did not specify specifically how the surgeons were to [address] consent. They did this all in their normal way, so that had variation," Dr. McFadden noted.

Consent discussions were audio recorded and transcribed, and the transcripts were analyzed for their content and grade level of the surgeon’s speech according to the Flesch-Kincaid scale.

Patients completed a 21-item recall checklist. Their recall score was calculated as the number of items recalled divided by the number the surgeon actually mentioned, multiplied by 100.

The patients’ mean age was 53 years; 83% were white and 66% had some college education or more, reported Dr. McFadden. On average, they had almost 15 years of education.

The percentage of physicians who mentioned various immediate risks of mesh ranged from 94% for bleeding to 97% for organ damage (mean, 95%). Patient recall scores at 6 weeks after surgery ranged from 71% for bleeding to 90% for the need for a catheter (mean, 80%).

The percentage of physicians who mentioned the long-term risks of mesh ranged from 30% for continued leakage and groin pain to 92% for mesh erosion, a notable high outlier (mean, 58%). Patient recall scores ranged from 33% for chronic urinary tract infection to 95% for continued leakage (mean, 68%).

Surgeons were significantly more likely to mention the immediate risks than the long-term risks (95% vs. 58%; P less than .01), but patients were similarly likely to recall these two groups of risks.

When referring to the midurethral sling implant, surgeons most commonly used the terms mesh (87%) and tape (81%), and less commonly used the term graft (14%). On average, there were 5.9 uses of mesh per consent session, 7.4 uses of tape, and 0.5 uses of graft.

A variety of sociodemographic factors (patient age, education, race/ethnicity, and health literacy score) and consent-related factors (duration of the discussion, mesh term used, and number of uses) were not significantly associated with patients’ recall of risks.

But the lower the grade level at which the surgeon spoke, the greater patients’ recall was (r = –0.26, P less than .05).

Dr. McFadden disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Patients giving consent to undergo midurethral sling surgery are more likely to remember being advised of the risks of surgical mesh if their surgeon speaks at a lower grade level.

This was among the key findings of a longitudinal cohort study of 71 women reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Analysis of the consent discussions, which lasted an average of 15 minutes, showed that surgeons were significantly more likely to mention the immediate risks of mesh than the long-term risks, reported first author Dr. Brook L. McFadden, a urogynecologist at the Ohio State University Wexner Medical Center in Columbus. But patients were equally likely to remember both groups of risks.

Neither the specific term surgeons used to refer to the midurethral sling implant – mesh, tape, or graft – nor the number of times they used the term during the discussion affected patients’ recall of mesh risks 6 weeks after surgery. The length of the discussion also had no significant impact.

However, the lower the grade level at which the surgeon spoke, the greater patients’ recall of risks, even though the cohort was fairly well educated. On average, the surgeons spoke at about the 6th- to 7th-grade level.

"This was a homogeneous, young, educated population, which may not be generalizable," Dr. McFadden noted. "And we cannot account for counseling that occurred prior to or after the surgical consent session that may have impacted recall."

Invited discussant Dr. Bela Kudish, a urogynecologist at the Winnie Palmer Hospital Center for Advanced Gynecologic Surgery and Pelvic Medicine in Orlando, noted, "As providers, many of us are trying to balance the principles of nonmaleficence, beneficence, and autonomy of the patient in an attempt to improve the counseling process, to emphasize the shared responsibility in decision making in patients who undergo this procedure."

"How are you planning to improve the study design to identify factors specific to the consent process that may influence the recall, since this was a study that was done in four centers with a nonstandardized consent process?" she asked the investigators.

"I think at this point, the surgical consent process is not limited to that moment that you sign papers. It starts in the first moment when you meet the patient. So I think we need to start broadening our understanding and our evaluation of the consent process to include the very beginning counseling that’s occurring from day 1. And I also think we need to spend more time trying to reconcile what patients want to know and what they think is important with what we want them to remember, maybe what the lawyers want them to remember, and try to make that more patient centered," Dr. McFadden replied at the meeting, which was jointly sponsored by the American College of Surgeons.

"In your opinion, what is the ideal way of counseling patients to increase the recall of risk?" Dr. Kudish further queried.

"I do try to spend time asking the patient, ‘How do you best learn? Is it written, is it verbal? Do you like pictures?’ And try to incorporate what works best for them. And I think that the utility of decisional aids, while we have presented work that did not show great use recently, that is where this is going to go: using decisional aids starting from the very beginning, day 1, up until surgery, and even beyond this," Dr. McFadden maintained.

Session cochair Dr. Andrew Cassidenti of St. Joseph Hospital, Orange, Calif., commented, "Your point is excellent. I think the informed consent is really your relationship with the patient. It’s not a document, it’s a relationship and it’s an understanding of your confidence, your capabilities, your experience, what you can do for them, your results, and an honest discussion. I think that really is the key to keeping lawyers at bay."

The study enrolled patients who could read and write English and were undergoing only midurethral sling surgery. "At these four centers, we did not specify specifically how the surgeons were to [address] consent. They did this all in their normal way, so that had variation," Dr. McFadden noted.

Consent discussions were audio recorded and transcribed, and the transcripts were analyzed for their content and grade level of the surgeon’s speech according to the Flesch-Kincaid scale.

Patients completed a 21-item recall checklist. Their recall score was calculated as the number of items recalled divided by the number the surgeon actually mentioned, multiplied by 100.

The patients’ mean age was 53 years; 83% were white and 66% had some college education or more, reported Dr. McFadden. On average, they had almost 15 years of education.

The percentage of physicians who mentioned various immediate risks of mesh ranged from 94% for bleeding to 97% for organ damage (mean, 95%). Patient recall scores at 6 weeks after surgery ranged from 71% for bleeding to 90% for the need for a catheter (mean, 80%).

The percentage of physicians who mentioned the long-term risks of mesh ranged from 30% for continued leakage and groin pain to 92% for mesh erosion, a notable high outlier (mean, 58%). Patient recall scores ranged from 33% for chronic urinary tract infection to 95% for continued leakage (mean, 68%).

Surgeons were significantly more likely to mention the immediate risks than the long-term risks (95% vs. 58%; P less than .01), but patients were similarly likely to recall these two groups of risks.

When referring to the midurethral sling implant, surgeons most commonly used the terms mesh (87%) and tape (81%), and less commonly used the term graft (14%). On average, there were 5.9 uses of mesh per consent session, 7.4 uses of tape, and 0.5 uses of graft.

A variety of sociodemographic factors (patient age, education, race/ethnicity, and health literacy score) and consent-related factors (duration of the discussion, mesh term used, and number of uses) were not significantly associated with patients’ recall of risks.

But the lower the grade level at which the surgeon spoke, the greater patients’ recall was (r = –0.26, P less than .05).

Dr. McFadden disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.